Differences in the proportion of women clinically cured at each visit between the two therapy arms will be evaluated using Fisher's-exact test. [ Time Frame: at each study visit ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ICMJE (submitted: August 1, 2007)

Differences in the proportion of women clinically cured at each visit between the two therapy arms will be evaluated using Fisher's-exact test.

Kaplan-Meier product-limit estimation will be used to obtain estimates of the median time to BV recurrence. [ Time Frame: at each study visit ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ICMJE (submitted: August 1, 2007)

Kaplan-Meier product-limit estimation will be used to obtain estimates of the median time to BV recurrence.

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

Official Title ICMJE

Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

Brief Summary

This research study is being done to evaluate the use of an oral (by mouth) medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps women from getting this infection back within 3 months. Tinidazole is currently approved by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis (BV).

This study will evaluate the use of tinidazole to treat a woman's current BV infection and then will look at using tinidazole as a suppressive treatment (taking medication regularly to attempt to decrease the "bad" bacteria from growing back). The suppressive treatment phase will include using tinidazole twice a week compared to using placebo twice a week and then following women for recurrence of BV. The purpose of this study is to determine if tinidazole suppression will prevent BV from coming back within 3 months of treatment.

The investigators hypothesize that women with a history of recurrent bacterial vaginosis who are randomized to a suppressive regimen (a dose of medication given on a regular basis to attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared to those women randomized to placebo.

Willing to refrain from alcohol consumption during use of study medication and three days following completion of medication (which includes the 10 day open label treatment and the entire 3 month suppressive phase of treatment).

Exclusion Criteria:

Known active sexually transmitted infection at the time of enrollment with C. trachomatis, N. gonorrhoeae, T. vaginalis, or active (symptomatic) vulvovaginal candidiasis.

Current use of anticoagulants/blood thinners (i.e. warfarin, coumadin, heparin).

Current use of any of the following medications: lithium, fluorouracil, anticonvulsant/seizure medications, Questran (cholestyramine) or CYP3A4 inducer/inhibitors (i.e. phenobarbital, rifampin, phenytoin, fosphenytoin).